Gilead asks FDA to revoke orphan drug status for potential coronavirus drug

Gilead Sciences Inc said on Wednesday it had requested the U.S. Food and Drug Administration to rescind the "orphan drug" status for its experimental coronavirus drug, remdesivir, amid backlash over the seven-year exclusivity that comes with the designation. Shares of the California-based company fell 5.3% to $70.7 in afternoon trading.

Senator Bernie Sanders has criticized U.S. President Donald Trump's administration for granting Gilead's drug the orphan designation, which also provides tax and other incentives and is reserved for treatments for rare diseases that affect fewer than 200,000 people. (https://bit.ly/2Ujkqrl) "Now is not the time for profiteering in the pharmaceutical industry," Sanders had said in a statement on Tuesday, where he asked the Trump administration to rescind the designation.

Gilead said it was confident of maintaining an expedited timeline for seeking regulatory review of remdesivir, without the orphan status. Remdesivir has been touted by many, including President Donald Trump, as one of the more promising potential treatments for the virus. The drug, which was initially tested as a treatment for Ebola, is now being tested in two late-stage studies for the coronavirus.

Drugmakers and medical researchers are stepping up their efforts to battle the coronavirus outbreak, which has infected nearly 35,400 people across the world and killed over 19,500. Other treatments being tested include generic malaria drug hydroxychloroquine and AbbVie Inc's HIV drug, Kaletra.